Breaking! Japan Implements the New Japanese Standards of Quasi-drug Ingredients (JSQI 2021)
Apr 16, 2021
Japan introduced the new JSQI, new permitted quasi-drug additives list and new quasi-drug application rules on March 25, 2021.
JSQI 2021 specifies 2,647 active quasi-drug ingredients and 84 test methods.
The new permitted quasi-drug additives list deleted one ingredient, modified 13 ingredients’ name and made content corrections.
The new quasi-drug application rules changed the previous requirements for the application for quasi-drugs manufacturing and marketing licenses.
On March 25, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) issued four documents, including the new Japanese Standards of Quasi-drug Ingredients (hereafter referred to as JSQI 2021), new List of Permitted Additives in Quasi-drugs, new Pre-market Application Rules of Quasi-drugs and a Collection of FAQs. In the above four documents, the ingredient standards are revised, and the corresponding pre-market application requirements of quasi-drug products are adjusted.
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